Diana & Mark Sherman v. Pliva, Inc, Teva Pharmaceuticals

440 P.3d 1016
CourtCourt of Appeals of Washington
DecidedApril 30, 2019
Docket50914-8
StatusPublished
Cited by7 cases

This text of 440 P.3d 1016 (Diana & Mark Sherman v. Pliva, Inc, Teva Pharmaceuticals) is published on Counsel Stack Legal Research, covering Court of Appeals of Washington primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Diana & Mark Sherman v. Pliva, Inc, Teva Pharmaceuticals, 440 P.3d 1016 (Wash. Ct. App. 2019).

Opinion

Filed Washington State Court of Appeals Division Two

April 30, 2019

IN THE COURT OF APPEALS OF THE STATE OF WASHINGTON

DIVISION II DIANA SHERMAN and MARK SHERMAN, No. 50914-8-II

Respondents,

v. PUBLISHED OPINION

PFIZER, INC., WYETH LLC (formerly known as WYETH, INC); WYETH HOLDINGS CORPORATION; WYETH PHARMACEUTICALS INC., SCHWARZ PHARMA, INC.; UCB, INC; ALAVEN PHARMACEUTICAL LLC, QUALITEST PHARMACEUTICALS, INC., GENERICS BIDCO I, LLC, RANBAXY PHARMACEUTICALS, INC.; GASTROENTEROLOGY ASSOCIATES, PLLC., GRACE KIM, RPh, ROBERTA MATTHEWS, RPh, RITE AID CORPORATION,

Defendants,

BRUCE A. SILVERMAN, M.D.,

Respondent,

TEVA PHARMACEUTICALS, INC., PLIVA, INC., BARR LABORATORIES, INC.,

Appellants.

MAXA, C.J. – PLIVA, Inc., Teva Pharmaceuticals USA, Inc., and Barr Laboratories, Inc.

(collectively Generic Defendants) appeal the trial court’s denial of their summary judgment

motion in a products liability lawsuit filed by Diana Sherman. No. 50914-8-II

The Generic Defendants are manufacturers of metoclopramide, the generic version of the

prescription drug Reglan. Sherman developed a movement disorder called tardive dyskinesia

after taking metoclopramide for six years as prescribed by Dr. Bruce Silverman. She filed a

lawsuit against the Generic Defendants, alleging that they had violated the Washington Product

Liability Act (WPLA), chapter 7.72 RCW, by failing to provide adequate warnings about the risk

of developing tardive dyskinesia associated with using metoclopramide.

Sherman’s duty to warn claim against the Generic Defendants derives from federally

approved changes to the Reglan label, also known as the “package insert,” that in 2004 and 2009

strengthened the warnings about using metoclopramide. Sherman claims that the Generic

Defendants violated their duty to warn in two ways. First, they failed to update their package

inserts for generic metoclopramide to reflect the strengthened warnings on the revised Reglan

labels. Second, they failed to communicate the strengthened warnings to Dr. Silverman and the

physician community in general in other ways besides in their package inserts.

We hold that the trial court erred in denying the Generic Defendants’ summary judgment

motion regarding (1) Sherman’s “failure to update” claim because Dr. Silverman’s testimony

that he did not read any package inserts precluded any genuine issue of fact as to whether the

Generic Defendants’ failure to update their metoclopramide warnings proximately caused her

tardive dyskinesia; and (2) Sherman’s “failure to communicate” claim because, under the facts of

this case, the Generic Defendants had no duty under the WPLA to communicate warnings by

means other than the package insert.1

1 The Generic Defendants also argue that federal law preempts any state law claims for failing to provide the strengthened warnings. Because we reverse on other grounds, we do not address this argument.

2 No. 50914-8-II

Accordingly, we reverse the trial court’s order denying the Generic Defendants’ summary

judgment motion and remand for the trial court to dismiss Sherman’s claims against the Generic

Defendants.

FACTS

Prescription for Metoclopramide

Metoclopramide is a prescription medication that is used for the treatment of

gastroesophageal reflux. A known risk of using metoclopramide includes the development of

tardive dyskinesia, a neurological disorder characterized by abnormal involuntary movements.

Sherman first saw Dr. Silverman in 2003 for severe digestive issues. After other

treatments failed to relieve Sherman’s symptoms, Dr. Silverman prescribed metoclopramide.

While on metoclopramide, Sherman’s digestive symptoms improved significantly. She stayed

on metoclopramide from September 2004 to December 2010.

Dr. Silverman evaluated Sherman regularly while she was on metoclopramide and before

2010 did not see any indication that she was experiencing involuntary movements. However, in

June 2010, Sherman began experiencing involuntary movements. In August 2011, she was

diagnosed with tardive dyskinesia.

Package Insert Warnings

Beginning in 1985, the package insert for Reglan contained a warning stating that tardive

dyskinesia may develop in patients treated with metoclopramide. The warning stated that the

risk of developing the syndrome was “believed to increase with the duration of treatment and the

total cumulative dose.” Clerk’s Papers (CP) at 715. The warning also stated that

“[e]xtrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in

approximately 1 in 500 patients” treated with metoclopramide. CP at 715. Under the dosage and

3 No. 50914-8-II

administration section, the package insert stated that “[t]herapy longer than 12 weeks has not

been evaluated and cannot be recommended.” CP at 716.

In 2004, the brand-name manufacturer revised the Reglan package insert. Both the

indications and usage section and the dosage and administration section of the revised package

insert contained a statement that therapy with metoclopramide “should not exceed 12 weeks in

duration.” CP at 766. There was no change to the reference to tardive dyskinesia in the

warnings section.

In 2009, the Food and Drug Administration (FDA) required the brand-name manufacturer

to add a “black box warning” to the Reglan package insert. CP at 84. The warning was placed at

the top of the package insert and stated:

WARNING

TARDIVE DYSKINESIA

Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

See WARNINGS.

CP at 503.

The warnings section of the revised package insert contained additional information

about tardive dyskinesia, including that “one published study reported a TD [tardive dyskinesia]

prevalence of 20% among patients treated for at least 12 weeks.” CP at 507. The warning

concluded, “Treatment with metoclopramide for longer than 12 weeks should be avoided in all

4 No. 50914-8-II

but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD.” CP

at 507.

Complaint

In 2013, Sherman filed a complaint against the Generic Defendants and others.2 In her

amended complaint, she asserted a WPLA claim against the Generic Defendants for failing to

provide adequate warnings to doctors regarding the use of metoclopramide. Specifically,

Sherman alleged that the Generic Defendants had breached their duty to provide adequate

warnings by failing (1) to update their package inserts for metoclopramide to match the

strengthened warnings added to the Reglan label in 2004 and 2009, and (2) to communicate the

new warning information in the revised Reglan labels to doctors through other means.

In his deposition, Dr. Silverman stated that he was aware when he prescribed

metoclopramide for Sherman that one of the potential risks was development of some sort of

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440 P.3d 1016, Counsel Stack Legal Research, https://law.counselstack.com/opinion/diana-mark-sherman-v-pliva-inc-teva-pharmaceuticals-washctapp-2019.